UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040035 |
|---|---|
| Receipt number | R000045642 |
| Scientific Title | Single-institution prospective observational study using intensity-modulated radiation therapy for cervical cancer |
| Date of disclosure of the study information | 2020/04/09 |
| Last modified on | 2020/04/13 12:18:45 |
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Basic information
Public title
Single-institution prospective observational study using intensity-modulated radiation therapy for cervical cancer
Acronym
Single-institution prospective observational study using intensity-modulated radiation therapy for cervical cancer
Scientific Title
Single-institution prospective observational study using intensity-modulated radiation therapy for cervical cancer
Scientific Title:Acronym
Single-institution prospective observational study using intensity-modulated radiation therapy for cervical cancer
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of definitive treatment using intensity-modulated radiation therapy(IMRT) for cervical cancer prospectively
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IMRT completion rate
Key secondary outcomes
Efficacy: overall survival, progression-free survival, locoregional control interval
Safety: incidence of adverse event
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Scheduled definitive treatment using IMRT for cervical cancer
2) 20 years old or older
3) Informed consent has been obtained
Key exclusion criteria
1) Informed consent has not been obtained
2) Inappropriate patient for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masahide |
| Middle name | |
| Last name | Anada |
Organization
Kagawa University Hospital
Division name
Department of Radiation Oncology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-898-5111
anada-m@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Anada |
Organization
Kagawa University Hospital
Division name
Department of Radiation Oncology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-898-5111
Homepage URL
anada-m@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
No research expenses required
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee, Kagawa University Faculty of Medicine
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
Tel
087-898-5111
kenkyushien@med.kagawa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
香川大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Efficacy and safety
Management information
Registered date
| 2020 | Year | 04 | Month | 02 | Day |
Last modified on
| 2020 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045642
